Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter
NCT ID: NCT00196118
Last Updated: 2007-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
800 participants
INTERVENTIONAL
2005-04-30
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Interventions
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Günther Tulip Vena Cava Filter
Eligibility Criteria
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Inclusion Criteria
* Patient must have a patent internal jugular vein.
* Patient has given informed consent.
Exclusion Criteria
* Patient has a pre-existing filter
* Patient had indications for a permanent filter at the time of the initial evaluation.
* Patient has uncontrollable coagulopathy.
* Patient has a short life expectancy \< 6 months.
* Patient has metastatic malignancy.
* Patient has a vena cava diameter over 30 mm, measured by vena cava sizing catheters.
* Patient has a contrast allergy that cannot be adequately pre-medicated.
* Patient is at risk of septic embolism.
* Patient has sepsis.
* Patient has a hypersensitivity to any of the components of the GT filter, specifically cobalt, nickel, and chromium.
* Patient has impaired renal function (creatinine \> 2.0).
* Patient is pregnant or planning to become pregnant within the next 6 months
18 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
Principal Investigators
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Bob Smouse, MD
Role: PRINCIPAL_INVESTIGATOR
Peoria Radiology Research & Education Foundation
Locations
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Christiana Hospital
Newark, Delaware, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Baptist Hospital of Miami, Inc.: Baptist Cardiac & Vascular Institute
Miami, Florida, United States
Atlanta Medical Center
Atlanta, Georgia, United States
University of Chicago Hospital
Chicago, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Spectrum Health Butterworth & Blodgett Campuses
Grand Rapids, Michigan, United States
Oregon Health & Sciences University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Utah Valley Regional Medical Center Department of Radiology
Provo, Utah, United States
LDS Hospital: Department of Radiology
Salt Lake City, Utah, United States
INOVA Alexandria
Alexandria, Virginia, United States
Countries
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Other Identifiers
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04-507-01
Identifier Type: -
Identifier Source: org_study_id